Validation of chromatographic analysis
Validacija hromatografske analize
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The parameters for the development of a chromatographic (HPLC) method and its validation are discused in the paper. Chromatographic analysis involves a multi-step procedure consisting of sample collection, pretreatment instrumental measurements and data processing. Emphasize was placed on the instrumental part of the analysis presuming that the contributions of the other variables were minor. The roles of precision, accuracy, detection limit, quantification limit, specificity, selectivity, range, linearity and robustness, as well as system suitability in the analytical application of chromatography were described. Recommendations for the validation of these parameters according to ICH and FDA guidelines are given. The criteria of validation described above can be almost completely applied to other instrumental chromatographic techniques such as GC, GC-MS, HPTLC, etc.
U radu su razmatrani parametri za razvoj i validaciju hromatografske analitičke metode. Opisana je uloga preciznosti, tačnosti, granice detekcije, granice kvantifikativnog određivanja, specifičnosti, opsega linearnosti i robustnosti, kao i pogodnosti sistema u analitičkoj primeni hromatografije. Date su preporuke za ove parametre u skladu sa ICH i FDA regulativom.
Keywords:
validation / HPLC / precision / accuracy / validacija / HPLC / preciznost / tačnostSource:
Hemijska industrija, 2002, 56, 2, 76-79Publisher:
- Association of Chemical Engineers of Serbia
Institution/Community
Tehnološko-metalurški fakultetTY - JOUR AU - Onjia, Antonije AU - Vasiljević, Tatjana AU - Čokeša, Đuro AU - Laušević, Mila PY - 2002 UR - http://TechnoRep.tmf.bg.ac.rs/handle/123456789/470 AB - The parameters for the development of a chromatographic (HPLC) method and its validation are discused in the paper. Chromatographic analysis involves a multi-step procedure consisting of sample collection, pretreatment instrumental measurements and data processing. Emphasize was placed on the instrumental part of the analysis presuming that the contributions of the other variables were minor. The roles of precision, accuracy, detection limit, quantification limit, specificity, selectivity, range, linearity and robustness, as well as system suitability in the analytical application of chromatography were described. Recommendations for the validation of these parameters according to ICH and FDA guidelines are given. The criteria of validation described above can be almost completely applied to other instrumental chromatographic techniques such as GC, GC-MS, HPTLC, etc. AB - U radu su razmatrani parametri za razvoj i validaciju hromatografske analitičke metode. Opisana je uloga preciznosti, tačnosti, granice detekcije, granice kvantifikativnog određivanja, specifičnosti, opsega linearnosti i robustnosti, kao i pogodnosti sistema u analitičkoj primeni hromatografije. Date su preporuke za ove parametre u skladu sa ICH i FDA regulativom. PB - Association of Chemical Engineers of Serbia T2 - Hemijska industrija T1 - Validation of chromatographic analysis T1 - Validacija hromatografske analize EP - 79 IS - 2 SP - 76 VL - 56 DO - 10.2298/HEMIND0202076O ER -
@article{ author = "Onjia, Antonije and Vasiljević, Tatjana and Čokeša, Đuro and Laušević, Mila", year = "2002", abstract = "The parameters for the development of a chromatographic (HPLC) method and its validation are discused in the paper. Chromatographic analysis involves a multi-step procedure consisting of sample collection, pretreatment instrumental measurements and data processing. Emphasize was placed on the instrumental part of the analysis presuming that the contributions of the other variables were minor. The roles of precision, accuracy, detection limit, quantification limit, specificity, selectivity, range, linearity and robustness, as well as system suitability in the analytical application of chromatography were described. Recommendations for the validation of these parameters according to ICH and FDA guidelines are given. The criteria of validation described above can be almost completely applied to other instrumental chromatographic techniques such as GC, GC-MS, HPTLC, etc., U radu su razmatrani parametri za razvoj i validaciju hromatografske analitičke metode. Opisana je uloga preciznosti, tačnosti, granice detekcije, granice kvantifikativnog određivanja, specifičnosti, opsega linearnosti i robustnosti, kao i pogodnosti sistema u analitičkoj primeni hromatografije. Date su preporuke za ove parametre u skladu sa ICH i FDA regulativom.", publisher = "Association of Chemical Engineers of Serbia", journal = "Hemijska industrija", title = "Validation of chromatographic analysis, Validacija hromatografske analize", pages = "79-76", number = "2", volume = "56", doi = "10.2298/HEMIND0202076O" }
Onjia, A., Vasiljević, T., Čokeša, Đ.,& Laušević, M.. (2002). Validation of chromatographic analysis. in Hemijska industrija Association of Chemical Engineers of Serbia., 56(2), 76-79. https://doi.org/10.2298/HEMIND0202076O
Onjia A, Vasiljević T, Čokeša Đ, Laušević M. Validation of chromatographic analysis. in Hemijska industrija. 2002;56(2):76-79. doi:10.2298/HEMIND0202076O .
Onjia, Antonije, Vasiljević, Tatjana, Čokeša, Đuro, Laušević, Mila, "Validation of chromatographic analysis" in Hemijska industrija, 56, no. 2 (2002):76-79, https://doi.org/10.2298/HEMIND0202076O . .